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Intensive management versus standard care in early psoriatic arthritis
DOI 10.1186/ISRCTN30147736
ClinicalTrials.gov identifier NCT01106079
EudraCT number 2007-004757-28
Public title Intensive management versus standard care in early psoriatic arthritis
Scientific title A randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis
Acronym TICOPA
Serial number at source 5221
Study hypothesis Tight control versus standard care of early psoriatic arthritis (less than 24 months disease duration).
Lay summary Not provided at time of registration
Ethics approval Northern and Yorkshire Research Ethics Committee (REC) approved on the 1st February 2008 (ref: 07/H0903/72)
Study design Randomised interventional treatment trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Participants - inclusion criteria 1. Consultant diagnosis of psoriatic arthritis (PsA)
2. Disease duration less than 24 months
3. Active disease
4. Ages greater than 18 years, either sex
5. Able to consent
Participants - exclusion criteria 1. Previous treatment with disease modifying anti-rheumatic drugs (DMARDs) for PsA
2. Under the age of 18 years
3. Pregnant women or planning pregnancy
4. Recent use of investigational drug
Anticipated start date 01/05/2008
Anticipated end date 01/01/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned Sample Size: 206; UK Sample Size: 206
Interventions A total of 206 patients will be randomised on an equal basis to receive either intensive management (4 weekly review) or standard care (12 weekly review). Each patient will participate in the study for 48 weeks. Those subjects randomised to the tight control arm will be reviewed every 4 weeks (by the PI at each site or a designated researcher) and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate.

Follow up length: 12 months
Study entry: Single Randomisation only
Primary outcome measure(s) The percentage of study patients achieving an ACR 20 response at 12 months.
Secondary outcome measure(s) Changes in clinical response over 6 and 12 months
Sources of funding 1. Arthritis Research UK (UK) - formerly Arthritis Research Campaign
2. Pfizer (UK) - formerly Wyeth Ltd
Trial website
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23517506
Contact name Ms  Nuria  Navarro Coy
  Address Senior Trial Manager
Clinical Trials Research Unit
University of Leeds
  City/town Leeds
  Zip/Postcode LS2 9JT
  Country United Kingdom
Sponsor University of Leeds (UK)
  Address -
  City/town Leeds
  Zip/Postcode LS2 9JT
  Country United Kingdom
  Sponsor website: http://www.leeds.ac.uk
Date applied 23/04/2010
Last edited 04/04/2013
Date ISRCTN assigned 23/04/2010
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